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Dosing Alternatives: Implementation Time and Effectiveness
There is a significant difference in the time it takes to relaunch a drug with a new dosing strength compared to a new dosing regimen. New dosing strengths have a less-complicated development process to undergo before a company can manufacture and market the relaunched drug. Dosing regimen changes, however, involve an additional understanding of how the drug will react with a patient’s metabolic processes. Therefore, switching from a three times per day dosing regimen to a once a day is far more complicated than simply putting three times as much active ingredient into one pill. The additional testing required, while basic in many respects, still adds time to the implementation process.

According to survey data, product teams take an average of 8.4 months to develop and relaunch a product with a new dosing strength. Although there are certainly examples of drugs that require the better part of three years to relaunch with a new dosing strength, the majority of companies require between one and four months to market the new product.

The data show that there are differences between developing a product with a new dosing strength versus one with a new dosing regimen. Rather than taking one to four months, most companies require between one and four years to relaunch a drug with a new dosing regimen. On average, a product team requires 20.0 months.

Although it may take more time on average to develop a new dosing regimen compared to a new dosing strength, there is little difference in the strategies’ effectiveness at protecting market share. Participating companies rated the effectiveness of both strategies on a scale of 1 to 5 where 5 represents the most effective strategy. New dosing strengths and regimens scored 3.5 and 3.4, respectively, on the scale.

New Indications: Strategy Cost
Because new indications relaunches are so similar in process to typical launches, development and implementation costs often reach into the hundreds of millions of dollars. Certainly, costs are still lower than launching a new drug from scratch, but they remain significant enough for companies to truly consider the impact of drug in a new market. A lot of companies will consider whether the investment in a new indication is worthwhile. Companies cannot promote off-label uses, but sometimes the off-label use is substantial enough to warrant a new trial. However, new clinical studies are costly and risky, so product teams may decide to leave their off-label use as is. There challenge with pursuing a new clinical trial is that out in the market, the off-label use helps the docs. But during a trial, a company may encounter a negative result because the trial may not be designed for all patients in the off-label indication. Those results are hard to calculate when the drug is already on the market and successful.

Among the relaunch strategies profiled in this study, new indications ranked as the most expensive, averaging $93.7 million, according to the survey data. Half of the survey respondents spent more than $100 million to relaunch their existing drug in a new indication. The high cost of implementing a new indications strategy may keep smaller pharmaceutical companies from going forward with what essentially amounts to a new launch. However, companies must recognize the importance of timing their new indication relaunch properly to maximize returns.